MAUDE Adverse Event Report: GENZYME CORP SYNVISC INJ 8MG/ML 3X2ML

Device Problem Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Patient Problem/Medical Problem (2688)

Event Date 07/12/2018

Event Type  Injury  

Event Description

Pt's husband reports she had a lot of swelling in her knee/leg and trouble standing up after synvisc injection last thursday.The pain and tightness starts above the knee and goes all the way to the ankle.Dates of use: (b)(6) 2018.Is the product compounded? no; is the product over-the-counter? no.

• Brand Name: SYNVISC INJ 8MG/ML 3X2ML
• Type of Device: SYNVISC INJ
• Manufacturer (Section D): GENZYME CORP
• MDR Report Key: 7705790
• MDR Text Key: 114716156
• Report Number: MW5078486
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009001
• UDI-Public: 58468009001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR